Device Recall Shape HF Cardiopulmonary System

DPIs with Lot Number 1405006 and higher.

Anesthesiology Devices

2

No

Nationwide Distribution

Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.